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FDA 510(k)

QUANTIEN Measurement System

K-Number: K172182 · 2017-08-18

ApplicantSt. Jude Medical (Now Part of the Abbott Medical)
Decision Date2017-08-18
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QUANTIEN Measurement System is a medical device manufactured by St. Jude Medical (Now Part of the Abbott Medical). It received FDA 510(k) clearance on 2017-08-18 under approval number K172182. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTIEN Measurement System?

QUANTIEN Measurement System is a medical device that received FDA 510(k) clearance on 2017-08-18. It is manufactured by St. Jude Medical (Now Part of the Abbott Medical). The 510(k) number is K172182.

When was QUANTIEN Measurement System approved by the FDA?

QUANTIEN Measurement System received FDA 510(k) clearance on 2017-08-18, under approval number K172182.

What company makes QUANTIEN Measurement System?

QUANTIEN Measurement System is manufactured by St. Jude Medical (Now Part of the Abbott Medical).

What is the FDA product code for QUANTIEN Measurement System?

The FDA product code for QUANTIEN Measurement System is DQK.

Related Clinical Trials

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Related PubMed Literature

PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

Related Devices (Code: DQK)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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